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Last Updated: September 19, 2020

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Claims for Patent: 8,029,817

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Summary for Patent: 8,029,817
Title:Silicon substituted oxyapatite
Abstract: The invention is a silicon substituted oxyapatite compound (Si-OAp) for use as a synthetic bone biomaterial either used alone or in biomaterial compositions. The silicon substituted oxyapatite compound has the formula Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x)/2, where 0<x<1.0.
Inventor(s): Sayer; Michael (Kingston, CA), Reid; Joel (Kingston, CA), Smith; Timothy J. N. (Kingston, CA), Hendry; Jason (Kingston, CA)
Assignee: Warsaw Orthopedic, Inc. (Warsaw, IN)
Application Number:12/245,554
Patent Claims:1. A silicon substituted oxyapatite composition comprising Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0, wherein the composition is a synthetic bone biomaterial that is biocompatible in vivo and wherein the composition is formed as a three-dimensional piece.

2. The silicon substituted oxyapatite composition of claim 1, wherein the composition further comprises one or more calcium phosphate compounds selected from the group consisting of oxyapatite, a silicon substituted tricalcium phosphate, hydroxyapatite, calcium hydroxyapatite, tricalcium phosphate, calcium oxide, alpha-tricalcium phosphate and beta-tricalcium phosphate.

3. The silicon substituted oxyapatite composition of claim 1, wherein the composition further comprises a silicon substituted tricalcium phosphate.

4. The silicon substituted oxyapatite composition of claim 1, wherein the composition further comprises an agent selected from the group consisting of calcium carbonate, calcitonin preparations, sex hormones, prostaglandin A1, bisphosphonic acids, ipriflavones, fluorine compounds, vitamin K, bone morphogenetic proteins (BMPs), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor (TGF-.beta.), insulin-like growth factors 1 and 2 (IGF-1, 2), endothelin, parathyroid hormone (pm), epidermal growth factor (EGF), leukemia inhibitory factor (LIP), osteogenin, bone and cartilage stimulating peptides (BCSP), bone resorption repressors and mixtures thereof.

5. The silicon substituted oxyapatite composition of claim 1, wherein the composition further comprises a bioresorbable polymer.

6. The silicon substituted oxyapatite composition of claim 5, wherein the bioresorbable polymer is selected from the group consisting of collagen, poly-lactic acid, poly-glycolic acid, copolymers of lactic acid and glycolic acid, chitosan, chitin, gelatin and mixtures thereof.

7. The silicon substituted oxyapatite composition of claim 5, wherein the bioresorbable polymer material reinforces a macroporous form of the Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0, compound.

8. A synthetic bone biomaterial formulated to promote bone repair and bone growth, the synthetic bone biomaterial comprising Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0, wherein the synthetic bone biomaterial is formulated as a powder, pellet or paste.

9. The synthetic bone biomaterial of claim 8, wherein the synthetic bone biomaterial further comprises one or more calcium compounds selected from the group consisting of a silicone substituted atricalcium phosphate, oxyapatite, hydroxyapatite, calcium hydroxyapatite, calcium oxide, alpha-tricalcium phosphate and beta-tricalcium phosphate.

10. The synthetic bone biomaterial of claim 8, wherein the synthetic bone biomaterial is mixed with tricalcium phosphate.

11. The synthetic bone biomaterial of claim 8, further comprising an agent selected from the group consisting of calcium carbonate, calcitonin preparations, sex hormones, prostaglandin AI, bisphosphonic acids, ipriflavones, fluorine compounds, vitamin K, bone morphogenetic proteins (BMPs), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor (TGF-.beta.), insulin-like growth factors 1 and 2 (IGF-1, 2), endothelin, parathyroid hormone (PTH), epidermal growth factor (EGF), leukemia inhibitory factor (LIP), osteogenin, bone and cartilage stimulating peptides (BCSP), bone resorption repressors and mixtures thereof.

12. The synthetic bone biomaterial of claim 8, further comprising a bioresorbable polymer.

13. The synthetic bone biomaterial of claim 12, wherein the bioresorbable polymer is selected from the group consisting of collagen, poly-lactic acid, poly-glycolic acid, copolymers of lactic acid and glycolic acid, chitosan, chitin, gelatin and mixtures thereof.

14. The synthetic bone biomaterial of claim 12, wherein the bioresorbable polymer material reinforces a particulate form of the Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0.

15. A synthetic bone biomaterial comprising a composition of the formula the Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0, wherein the composition is produced by a method comprising: mixing a calcium phosphate colloidal suspension with a finely dispersed, fumed silica; while maintaining a ratio of Ca/(P+Si) at about 1.67 in the mixture; sintering the mixture for about 1 hour at a temperature between about 1000.degree. C. to about 1200.degree. C. under a vacuum; and producing a composition comprising Ca.sub.5(PO.sub.4).sub.3-x(SiO.sub.4).sub.xO.sub.(1-x/2), where 0<x<1.0.

16. The synthetic bone biomaterial of claim 15, comprising sintering the mixture at a temperature of about 1175.degree. C.

17. The synthetic bone biomaterial of claim 15, comprising applying a vacuum between about 5.times.10.sup.4 torr to about 1.times.10.sup.5 torr.

18. The synthetic bone biomaterial of claim 15, comprising providing the silicon at a concentration of between about 0.5 mol SiO.sub.2:mol hydroxyapatite to about 1.5 mol SiO.sub.2:mol hydroxyapatite.

19. The synthetic bone biomaterial of claim 15, comprising providing the silicon at a concentration of between about 2.6 to 7.1 wt % silicon.

Details for Patent 8,029,817

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Warsaw Orthopedic, Inc. (Warsaw, IN) 2024-04-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Warsaw Orthopedic, Inc. (Warsaw, IN) 2024-04-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Warsaw Orthopedic, Inc. (Warsaw, IN) 2024-04-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Start Trial Warsaw Orthopedic, Inc. (Warsaw, IN) 2024-04-07 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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